Indirect Treatment Comparisons in Healthcare Decision Making: A Targeted Review of Regulatory Approval, Reimbursement, and Pricing Recommendations Globally for Oncology Drugs in 2021-2023 (nov,10.1007/s12325-024-03013-6,2024)

被引：0

作者：

Igarashi, Ataru ^{[1
]}

Tanaka, Shiro ^{[2
]}

Moor, Raf De ^{[3
]}

Li, Nan ^{[3
]}

Hirozane, Mariko ^{[4
]}

Wu, David Bin-Chia ^{[5
,6
]}

Hong, Li Wen ^{[5
]}

Yu, Dae Young ^{[5
]}

Hashim, Mahmoud ^{[7
]}

Hutton, Brian ^{[8
]}

Tantakoun, Krista ^{[9
]}

Olsen, Christopher ^{[9
]}

Fashami, Fatemeh Mirzayeh ^{[9
]}

Samjoo, Imtiaz A. ^{[9
]}

Cameron, Chris ^{[9
]}

机构：

[1] Yokohama City Univ, Unit Publ Hlth & Prevent Med, Kanazawa Ward, Sch Med, Yokohama, Kanagawa, Japan

[2] Kyoto Univ, Grad Sch Med, Kyoto, Japan

[3] Janssen Pharmaceut KK, Value Evidence & Access Dept, IMAT, Tokyo, Japan

[4] Janssen Pharmaceut KK, Policy Dept, IMAT, Tokyo, Japan

[5] Janssen Pharmaceut Co Johnson & Johnson, Asia Pacific Reg Market Access, Singapore, Singapore

[6] Natl Univ Singapore, Saw Swee Hock Sch Publ Hlth, Singapore, Singapore

[7] Johnson & Johnson Global Commercial Strategy Org, Beerse, Belgium

[8] Ottawa Hosp Res Inst, Ottawa, ON, Canada

[9] EVERSANA, Burlington, ON, Canada

来源：

ADVANCES IN THERAPY | 2025年 / 42卷 / 01期

关键词：

Health technology assessment; Indirect treatment comparison; Policy;

D O I：

10.1007/s12325-024-03087-2

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

IntroductionIndirect treatment comparisons (ITCs) evaluate novel treatments compared to appropriate comparators when direct evidence is unavailable or infeasible. The objective of this study was to highlight the prevalence of different ITC methods in oncology drug submissions and to provide insights into how ITCs have been used in recent regulatory approval, reimbursement recommendations, or pricing decisions across various regions and diverse assessment frameworks.MethodsA targeted literature review was conducted to identify assessment documents for oncology drug submissions that included ITCs. This included hand searches of the websites of four regulatory bodies and four health technology assessment (HTA) agencies with varying assessment frameworks across North America, Europe, and Asia-Pacific.ResultsA total of 185 documents were included for synthesis. Documents were retrieved from all four HTA agencies and the European Medicines Agency (EMA), the only regulatory body with eligible records. Within these, 188 unique submissions included a total of 306 supporting ITCs of various methods. Authorities more frequently favored anchored or population-adjusted ITC techniques for their effectiveness in data adjustment and bias mitigation. Furthermore, ITCs in orphan drug submissions more frequently led to positive decisions compared to non-orphan submissions.ConclusionsThis review highlights the crucial role and widespread use of ITCs in global healthcare decision-making, particularly when direct evidence is lacking, and in the discernment of market-specific clinical benefits. This work contributes to bolstering the credibility and recognition of ITCs across regulatory and HTA agencies of diverse regions and assessment frameworks.

引用

页码：70 / 71

页数：2